Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-004253
    NCT ID: NCT03115424
    Sponsor Protocol Number: 16-004253

About this study

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Age 20-65 years of age
  2. Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.
  3. No active physical illness which will interfere with mobility or weight loss after bariatric surgery.
  4. Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

Exclusion Criteria:

  1. Prior use of glucose lowering medication in the 3 months prior to screening.
  2. A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.
  3. Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
  4. Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
  5. Hypersensitivity to liraglutide or any product components.
  6. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.
  7. Prior history of pancreatitis, cholelithiasis or cholecystitis.
  8. Concurrent use of insulin or any other GLP-1 receptor agonist.
  9. Active, severe psychiatric disease

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Open for enrollment

Contact information:

Paula Giesler R.N.

(507)255-8345

Giesler.Paula@mayo.edu

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CLS-20313154

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